A Relation Between Craving Induction and Treatment Response in Deep Transcranial Magnetic Stimulation (dTMS) for Reducing Antipsychotic-induced Weight Gain in Schizophrenia (dTMS)
1 septembre 2026 mis à jour par: Ping Shao, Second Xiangya Hospital of Central South University
The Study of Improving Antipsychotic-induced Appetite by Deep Transcranial Magnetic Stimulation: The Effects of Improving Antipsychotic-induced Appetite by Single Session dTMS After Food Cue-induced Craving, A Randomized, Crossover and Sham-Controlled Trail
Antipsychotic-induced metabolic disturbances, especially weight gain, are common in patients with schizophrenia.
Furthermore, it is reported significant changes in food intake happened in patients with weight gain after intaking antipsychotics.
There are no hitherto effective treatments for reducing antipsychotic-induced weight gain.
dTMS which is a safe and non-invasive physical treatment indicates greater efficacy than other transcranial magnetic stimulation (TMS) by some research.
Apart from that, symptom provocation is believed to improve the clinical responses to TMS.
In this study, the investigators, firstly, evaluate the safety and effectiveness of dTMS for reducing antipsychotic-induced weight gain and secondly, unveil whether symptom provocation can affect the clinical responses to TMS.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
The underlying causes of antipsychotic-induced weight gain are still unknown. Some research point out that it has something to do with metabolic disturbances and changes in appetite and food intake. With fMRI study, it is reported having dysfunction between prefrontal and insula cortex of its cognitive regulation, interoceptive signals and reward control. dTMS, H4 coil in particular, simultaneously targets prefrontal and insula cortex. Previous study has been deconstrued that dTMS could significantly improve weight gain. Moreover, it is reckoned that TMS has state-dependent effects on brain circuitry, suspected that symptom provocation may be made it more susceptible to modulation which may improve response. Therefore, this study is to explore the efficacy of dTMS on antipsychotic-induced appetite, and whether provoking symptoms can improve dTMS clinical responses.
With regard to investigate this, the investigators will be carried out a randomized single session dTMS, crossover, sham controlled clinical trial. 30 Patients with schizophrenia will be randomly treated with dTMS after food cue induced craving (FCC), dTMS without FCC and sham condition without FCC. Each session has three days intervals for washout. The follow-ups are at the baseline and after each session immediately. The main outcome measures include the change in Food-Cravings Questionnaires state (FCQ-S) score, Visual Analogue Scale (VAS) score, changes in Stop-Signal test (SST) behavioral assessment and the resting-state functional magnetic resonance imaging data.
Type d'étude
Interventionnel
Inscription (Estimé)
30
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Ping Shao
- Numéro de téléphone: +86-13755112445
- E-mail: shp97jw@163.com
Sauvegarde des contacts de l'étude
- Nom: Renrong Wu
- Numéro de téléphone: +86-15874179855
- E-mail: wurenrong@csu.edu.cn
Lieux d'étude
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Hunan
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Changsha, Hunan, Chine, 410011
- The Second Xiangya Hospital of Central South University
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Contact:
- KaHei Chan
- Numéro de téléphone: +86-18890384723
- E-mail: heimradchan@foxmail.com
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Aged between 18-60
- Meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for schizophrenia, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5).
- Gaining body weight around 7% after intaking antipsychotics within 2 years
- Participants were on a stable medication regimen at the time of enrollment
- Written informed consent was obtained from both the participants and their legally authorized guardians
Exclusion Criteria:
- Participants who switch antipsychotic drugs (APDs) or require a dose modification exceeding 25% of the baseline dosage during the study period.
- Diagnosed with other mental diseases in accordance with DSM-V
- Comorbid with other severe physiological diseases
- Active suicidal ideation
- A history of alcohol or substance use disorder (or abuse)
- Presence of metal implants or any other conditions contraindicated for magnetic resonance imaging (MRI)
- Presence of intracranial metal or electronic devices, a personal or family history of epilepsy, or any other standard contraindications to deep transcranial magnetic stimulation
- Receipt of regular repetitive transcranial magnetic stimulation (rTMS), electroconvulsive therapy (ECT), or weight-loss interventions within the past month
- Pregnant or lactating women
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Active dTMS after food cue induced craving (dTMS+FCC)
Participants will receive single session of active-dTMS to the bilateral insula and prefrontal cortex with H4 coil after food cue induced craving by watching the personalized video based on each participant's favorite food choices
|
The study will utilize the H4 coil to administer active Deep Transcranial Magnetic Stimulation (dTMS) to the bilateral insula and prefrontal cortex by Intermittent theta burst stimulation (iTBS).
The stimulation intensity is set at 90% of resting motor threshold (RMT), and the other parameters are set to triplet 50Hz bursts, repeat at 5Hz, 2s seconds on and 8 seconds off, 1800 pulses per session, total duration of 9 minutes and 52 seconds.
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|
Comparateur actif: Active dTMS after non food cue induced craving (dTMS+NON FCC)
Participants will receive single session of active-dTMS to the bilateral insula and prefrontal cortex with H4 coil after neural visual stimulation by watching non-food and non-food related video
|
The study will utilize the H4 coil to administer active Deep Transcranial Magnetic Stimulation (dTMS) to the bilateral insula and prefrontal cortex by Intermittent theta burst stimulation (iTBS).
The stimulation intensity is set at 90% of resting motor threshold (RMT), and the other parameters are set to triplet 50Hz bursts, repeat at 5Hz, 2s seconds on and 8 seconds off, 1800 pulses per session, total duration of 9 minutes and 52 seconds.
|
|
Comparateur factice: Sham dTMS after non food cue induced craving (SHAM dTMS+NON FCC)
Participants will receive single session of sham-dTMS to the bilateral insula and prefrontal cortex with H4 coil after neural visual stimulation by watching non-food and non-food related video
|
L'étude utilisera un protocole identique utilisant la bobine H4 pour administrer une condition fictive.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Food Craving Questionnaire State, FCQ-S
Délai: Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
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The assessment of food cravings.
The FCQs consists of 15 items to be scored on a 5-point scale ranging from strongly disagree to strongly agree.
Its original form comprises five subscales measuring current food craving in relation to (1) an intense desire to eat, (2) anticipation of positive reinforcement, (3) relief from negative states, (4) lack of control over eating, and (5) hunger.
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Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Visual Analogue Scale, VAS
Délai: Assessed at three time points (pre-provocation, immediately post-provocation [within 5 min], and immediately post-dTMS [within 30 min]) on Study Days 1, 5, and 9.
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The Visual Analogue Scales required the subjects to rate hunger, satiety, thirst, fullness and emptiness on a 0-100 mm scale.
The Visual Analogue Scales of Craving was assessed two times: before the provocation procedure, and after the provocation procedure
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Assessed at three time points (pre-provocation, immediately post-provocation [within 5 min], and immediately post-dTMS [within 30 min]) on Study Days 1, 5, and 9.
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Changes of Stop-Signal mean reaction time (SSRT)
Délai: Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
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The SST aims to access cognitive behavioral inhibition control.
The study employed a task that comprised randomly interleaved NoGo and Stop-Signal trials to examine both types of inhibition.
The study measured six behavioral parameters of interest: namely Mean Go reaction time (GoRT), Stop-Signal mean reaction time (SSRT), Stop-Signal delay (SSD), Target accuracy, Go trial accuracy, and NoGo Accuracy.
The SST main outcome is the changes of Stop-Signal mean reaction time (SSRT)
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Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
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Resting-state functional magnetic resonance imaging
Délai: Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
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All patients undergo head MRI scans in Philips Achieva 3.0 T scanner and SIEMENS Prisma 3.0 T scanner.
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Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
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Task-state functional magnetic resonance imaging
Délai: Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
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Measure of the immediate activation (blood-oxygen-level-dependent change) in the brain regions related to appetite neural circuits under food cue reactivity task
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Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
1 mai 2027
Achèvement de l'étude (Estimé)
1 juin 2027
Dates d'inscription aux études
Première soumission
26 août 2026
Première soumission répondant aux critères de contrôle qualité
1 septembre 2026
Première publication (Réel)
8 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
8 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- LYEC2026-0195
- 82571770 (Autre subvention/numéro de financement: National Natural Science Foundation of China)
Plan pour les données individuelles des participants (IPD)
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NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
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